Recent advances in medical technology have made it possible to implant a prosthetic valve device into a native heart valve orifice using a transcatheter procedure. The use of a transcatheter procedure instead of open-heart surgery has many advantages, among them, a significant reduction in the risk, cost, and recovery time that is traditionally associated with heart surgery.
In one such transcatheter valve implantation procedure, a delivery catheter is advanced through an opening formed in the apex of the heart to the site where the prosthetic valve is to be implanted. A prosthetic valve device used in such a procedure is disclosed in U.S. Patent Application No. Application 2006/0149360 to Schwammenthal, et al. which describes an expandable stent-mounted valve specially adapted for implantation into a native valve orifice. The stent-mounted valve is loaded in a compressed state inside of the delivery catheter. When the implantation site is reached, the stent-mounted valve is released from the catheter and automatically assumes the proper position in the valve so as to restore proper blood flow through the valve.
Following implantation of the valve, it is necessary to close the opening which was formed in the heart apex. It would be desirable to perform such closing in conjunction with the transcatheter procedure, so that a separate procedure would not be required.
A variety of devices are known in the art for suturing an opening formed in a body lumen. For example, Japanese Patent No. 2001198132 relates to a suturing device for closing an opening following an operation. Suturing after a lesion is incised is made possible by rotating a hollow and spiral suturing needle with curvature around the center of the curvature as a shaft.
U.S. Pat. No. 5,626,613 to Schmieding et al., relates to a corkscrew suture anchor having a spiral-shaped body with a hollow central core, a distal end, and a proximal end. The distal end of the spiral body terminates in a sharp point, and the proximal end of the spiral-shaped body has an eye for receiving suture.
U.S. Pat. No. 6,916,333, also to Schmieding et al., relates to a corkscrew suture anchor has a continuous thread spiraling around a tapering central core. At the distal end, the suture anchor terminates in a rounded point. At the proximal end of the suture anchor is an eye for receiving suture.
Russian Patent No. 2119771 relates to a device having a casing with an unmovable working lip, movable working lip and handles. A mechanism for suturing is enclosed in the casing.
Korean Patent Disclosure No. 20040075834 relates to a laparoscopic suture instrument for allowing ease of surgery by removing a hinge between devices for holding suture needles and integrating suture needles and a handle.
None of the aforementioned prior art references provide a suturing device that is suitable for use in conjunction with a transcatheter procedure and specifically, for closing an opening formed in the apex of the heart following implantation of a prosthetic valve device.